Background/aims To understand changes in disease activity as assessed by leakage and retinal fluid status in patients with neovascular age-related macular degeneration (nAMD) receiving fixed dosing with an anti-vascular endothelial growth factor (anti-VEGF) agent.
Methods In the phase III VIEW 1 (NCT00509795) and VIEW 2 (NCT00637377) studies, eyes with nAMD were treated with intravitreal aflibercept or ranibizumab. Independent, masked reading centres determined the presence/absence of leakage (fluorescein angiography) and retinal fluid (optical coherence tomography) at baseline, week 24 and week 52. In this integrated, post hoc analysis of the VIEW studies, the relationship between leakage/fluid status and best-corrected visual acuity (BCVA) was assessed. The impact of baseline lesion type (predominantly classic (PC), minimally classic (MC), occult) was also evaluated. Data from all treatment groups were pooled.
Results 2373 eyes were included in this analysis. At baseline, 95.4% of eyes presented with both leakage and fluid. By week 52, leakage and fluid were present in 16.0% of eyes. Mean BCVA gains at week 52 were numerically greater in eyes without leakage and fluid versus eyes with both leakage and fluid (10.3 vs 9.2 letters). At week 52, 11.6%, 15.3% and 20.1% of eyes with PC, MC and occult lesions, respectively, had both leakage and fluid present.
Conclusion In this post hoc analysis, fixed dosing with an anti-VEGF agent over 52 weeks eliminated disease activity (absence of both leakage and fluid) in most eyes. The effect of anti-VEGF treatment on leakage/fluid status favoured PC versus occult lesions.
- clinical trial
- treatment medical
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Contributors All authors contributed to the design of this post hoc analysis, data acquisition/research execution, data analysis/interpretation and manuscript preparation. The authors were responsible for all content and editorial decisions.
Funding VIEW 1 and VIEW 2 were funded by Regeneron Pharmaceuticals, Inc., Tarrytown, New York, and Bayer HealthCare, Berlin, Germany. The sponsors participated in the design and conduct of these studies, analysis of the data and preparation of this manuscript.
Competing interests DMM has the following disclosures: 1800 Contacts (Board of Directors, equity), Akebia (Consulting for ROP), Alcon (Data Safety Monitoring Board), Allegro (SAB), Apellis (Site PI), Bayer (ROP Imaging Committee), Congruence Medical Solutions (Consultant), dSentz (Founder, Board of Directors, equity), Iconic Therapeutics (Steering Committee), Irenix (SAB), Grand Legend Technology (Equity), Linc (Founder, Equity, Board of Directors), Novartis (Data Safety Monitoring Board), Pr3vent (Founder, Board of Directors, equity), Prime (CME consultant), Promisight (Founder, Board of Directors, equity), Pykus (SAB, equity), Regeneron (CME consultant, ROP Steering Committee), Shapiro Law (ROP expert witness), Versl (Founder, equity), Vindico (CME consultant), Visunex Medical Systems, Co (SAB, equity). DT and NS were salaried employees of Regeneron Pharmaceuticals, Inc. at the time that these analyses were undertaken. Both are paid consultants to Regeneron Pharmaceuticals, Inc. NS also serves as a consultant to Aerie, Allegro, Apellis, Adverum, RegenexBio, and SamaCare and is an equity owner in Allegro, Pr3vent, and SamaCare.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.